FDA Adverse Event
Death
Summary report: N
TRIATHLON PRIM TIB BASEPLATE - CEMENTED
MDR report key: 6407196
·
Received March 15, 2017
Report
- Report Number
- 0002249697-2017-00924
- Event Type
- Death
- Date Received
- March 15, 2017
- Date of Event
- February 17, 2017
- Report Date
- March 15, 2017
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- MBH
- PMA / PMN Number
- K141056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED.
Description of Event or Problem · 1
LAWYER REPRESENTING HOSPITAL REPORTS PATIENT WAS IMPLANTED WITH TRIATHLON PROSTHESIS AND WAS ALLERGIC TO NICKEL SULPHIDE. PATIENT DEVEOPED INFECTION AND PASSED AWAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 189575 | TRIATHLON PRIM TIB BASEPLATE - CEMENTED | PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO | MBH | STRYKER ORTHOPAEDICS-MAHWAH | EEEJN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| H |